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Regional Regulatory Affairs Manager - Agensi Pekerjaan Career Track - Selangor
http://www.jobs-in-malaysia.dearlinks.com/articles/1992/1/Regional-Regulatory-Affairs-Manager---Agensi-Pekerjaan-Career-Track---Selangor/Page1.html
By Super Admin
Published on 09/22/2011
 

Candidate must possess at least a Bachelor's Degree, Post Graduate Diploma, Professional Degree, Medical Science or equivalent.
Required language(s): Bahasa Malaysia, English
At least 2 year(s) of working experience in the related field is required for this position.
Preferably Senior Managers specializing in Healthcare - Pharmacy or equivalent.
Full-Time positions available.


Regional Regulatory Affairs Manager

Responsibilities:
Ensure that comprehensive records of communications, country requirements and regulatory status, are maintained.
Contributes to the development of filing and approval goals for the region.
To manage projects and product-related registration strategies in the assigned countries.
To ensure that regulatory documentation meet relevant regulatory requirements.
To apply knowledge of regulatory requirements in the assigned countries to the drug development process.
Partners with relevant functional teams, Commercial, Business and Development teams.
Apply regulatory expertise for assigned countries to enable preparation of high quality documentation and assure compliance with departmental procedures.
Ensure notifications of proposed regulatory changes and approvals are communicated to relevant stakeholders in a timely manner.
Develop detailed understanding of regulatory guidelines and technical requirements in assigned countries
Participate and/or lead cross-functional project teams, to address business needs in line with Medical Departments, and County business objectives.

Requirements:
Candidate must possess at least a Bachelor's Degree, Post Graduate Diploma, Professional Degree, Medical Science or equivalent.
Required language(s): Bahasa Malaysia, English
At least 2 year(s) of working experience in the related field is required for this position.
Preferably Senior Managers specializing in Healthcare - Pharmacy or equivalent.
Full-Time positions available.

Interested applicants please email a copy of your updated
resume to job@ecareertrack.com. Please indicate the position

you are applying for.